A Phase 4 interventional study of Fimasartan and Placebo in Coronary Artery Disease, sponsored by Seung-Jung Park. Terminated at 3 sites in Korea, Republic of. Open to participants aged 19 Years to 84 Years. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by Seung-Jung Park · Phase 4, Interventional, and Treatment
Prospective, double-blind, randomized clinical study with enrollment of patients over at least 18 years of age who require coronary angiography for a clinical indication with hypertension defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg. Inclusion requires at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis >50% without any evidence of inducible ischemia. The target vessel for IVUS interrogation must not have undergone angioplasty (deferred lesion) nor have more than 50% luminal narrowing throughout a target segment. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 (Fimasartan 60-120 mg vs placebo). All subjects will be followed up at 1 year for serial VH-IVUS and conventional IVUS evaluation. Also, OCT sub-study will be performed in selected patients with lesions at least 20 mm distally located from coronary ostium. All patients will be blindly assigned to control and Fimasartan once daily as 1:1 ratio and are prescribed for 1year.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 186 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.
Drug: Fimasartan
Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.
Drug: Placebo
60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)
Also known as: Kanarb Tab.
60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)
Change in percent necrotic core (NC) volume of plaque by VH (Virtual Histology) in the "target segment" (within deferred vessel)
Time frame: baseline and 1 year
Change of total atheroma volume (TAV) and percent atheroma volume (PAV) of the target segment and the most diseased 10-mm segment (normalized to different segment length) with the largest plaque volume
Time frame: baseline and 1 year
Percent change in minimal lumen area (MLA) in target segment
Time frame: baseline and 1 year
Change of absolute area or percentages (%) of each plaque VH composition (fibrotic, fibrofatty, dense calcium, necrotic core) at minimal lumen area (MLA) and largest necrotic core area within the target segment
Time frame: baseline and 1 year
Change of VH-IVUS (Intra Vascular UltraSound) detected plaque type from baseline
Time frame: at 1 year
Change of percentage (%) of OCT (Optical Coherence Tomography)-defined TCFA (Thin Cap Fibrotic Atheroma) within the target segment from baseline
Time frame: at 1 year
Change of composition of OCT-defined fibrous, fibro-calcific, and lipid-rich plaque within the target segment
Time frame: baseline and 1 year
Change of OCT-defined fibrous cap thickness, the presence of plaque disruption, calcification or intraluminal thrombus within the target segment
Time frame: baseline and 1 year
Change of FFR in target segment from baseline
Time frame: at 1 year
systolic and diastolic blood pressure
Time frame: at 1 year follow-up
Change in high sensitive CRP (C-Reactive Protein)from baseline
Time frame: at 1 year
Plan to share: No — This is not a publicly funded trial.
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Seung-Jung Park